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Completed

NCT Number: NCT02151669

Diet Intervention Spirometry and Tobacco

Epidemiologic studies suggest that some nutrients can be affected lung function. Moreover, no previous studies have prospectively evaluated the effect of the Mediterranean dietary pattern in lung function in smokers. Phase II of the RESET study , a clinical trial to evaluate the efficacy of a motivational smoking intervention based on information obtained by spirometry (FIS project PI11/01962).

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Key information

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unitat de Recerca. CAP Sant Pere

Reus, Tarragona, 43202, Spain

About this study

Design: Multicenter randomized controlled trial in primary care. Sample: We will recruit 80 smokers from 35 to 70 years without history of lung disease. Subjects will be randomly assigned to control or intervention group (1:1).

Study variables: We measure socio-demographic, clinical, anthropometry and spirometry data. Food consumption will be evaluated by a semi-quantitative food frequency questionnaire (FFQ), energy expenditure in physical activity by the Minnesota Leisure Time Activity questionnaire and adherence to Mediterranean Diet by a 14-item questionnaire.

Intervention: Nutritional intervention conducted by a dietitian who designs a nutrition program to enhance the traditional Mediterranean diet pattern using new technology as an educational tool in primary care: DIET blog. Participants will be referred to a single annual visit and one group session per year for two years.

Analysis: All analyses will be based on intention-to-treat. The results will be considered clinically relevant when it detects a difference in lung function (decreased FEV1) >10-12 ml/year. A p-value of <0.05 will defined statistical significance.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Being active smokers at the time of enrollment with an cumulative consumption more than 10 packs / year
  • Having Internet access and regular use of new technologies in general or have help for it.
  • Having participated in the first phase of the project: RESET study (PI11/01962).

Exclusion criteria

  • Any evidence of previous diagnosis of respiratory disease,
  • Suffering from a terminal or chronic disorder that alters the baseline parameters or hinder the completion of testing and required test during the study period,
  • Inability to track for any reason,
  • Express refusal of the patient to continue in the study

Treatment and study plan

Mediterranean Diet

Behavioral

Nutritional intervention conducted by a dietitian who designs a nutrition program to enhance the traditional Mediterranean diet pattern using new technology as an educational tool in primary care: DIET blog. Participants will be referred to a single annual visit and one group session per year for two years.

Primary outcomes

  1. Changes in lung function

    Time frame: 2 years

    Assess the relationship between lung function and adherence to a Mediterranean Diet and its components

Secondary outcomes

  1. Lung function and anthropometric parameters

    Time frame: 2 years

    Assess the relationship between lung function and anthropometric parameters such as waist circumference and BMI.

  2. Lung function and effectiveness of a nutritional educational tool 2.0

    Time frame: 2 years

    To evaluate the effectiveness of using an nutritional educational tool 2.0 to increase adherence to a Mediterranean diet: blog.

Sponsors and collaborators

Lead sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Other

Collaborators

  • Preventive Services and Health Promotion Research Network

Registry information

Official study title

EFFECT OF A MEDITERRANEAN DIET INTERVENTION IN PULMONARY FUNCTION IN SMOKERS: A MULTICENTER RANDOMIZED CLINICAL TRIAL IN PRIMARY CARE CENTERS

Acronym: DIET

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
May 30, 2014
Registry last updated
Feb 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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